Doctors Debate the Safety of Celebrex

Dec. 17, 2004 — -- Concerns that Celebrex may increase the risk of heart attack could keep what is still a relatively safe medication away from patients who suffer from arthritis and other painful ailments, some doctors say.

Pfizer Inc. said today one study had shown an increased risk of heart attacks among some patients using Celebrex, but the drug giant said it had no plans to pull the popular painkiller from the market.

"My concern is that we have some drugs that clearly benefit patients who are now being deprived of these drugs because of the medical-legal environment in this country," said Dr. Mark Lema, chairman of the Department of Anesthesiology at the University at Buffalo, part of the State University of New York system.

Celebrex belongs to a class of pain relievers known as COX-2 inhibitors. These drugs have been shown to relieve pain without the risks of gastrointestinal bleeding and ulcers. Pain relievers like aspirin, ibuprofen and other non-steroidal anti-inflammatory drugs have been associated with gastrointestinal problems.

"You have to put this whole COX-2 thing into perspective," said Lema. "These were designed to be safer in patients who cannot take NSAIDs. They'll have to go back on NSAIDs with antacids and they, too, have their own risks."

Lema notes that each year, about 100,000 people are hospitalized and about 16,000 patients die from problems associated with NSAIDs.

"The goal was to try to prevent those deaths," said Dr. Raymond L. Woosley, vice president for health sciences at the University of Arizona in Tucson. "The belief was that we would save more lives by preventing ulcers and bleeding from ulcer disease than would be lost from heart attacks."

But many of the patients who received prescriptions for Celebrex and Vioxx (another COX-2 drug that was pulled from shelves earlier this year over similar safety concerns), were not in a high-risk group for gastrointestinal problems and should probably have never been prescribed either of the two drugs.

"In my view, both were heavily over-prescribed right from the start, probably because of heavy promotion and the urge for everyone to use the 'latest thing,' " said Dr. Tom Dean, a family practitioner from Wessington Springs, S.D.

"These drugs never presented any advantage as far as effectiveness is concerned. They were associated with less stomach irritation," said Dean.

Doctors and patients are now struggling over what to do with this new information regarding COX-2 pain medications.

"The default position has been, if they're on Vioxx, get them on Celebrex, but that position is going up in smoke," said Paul Doering, professor of pharmacology in the College of Pharmacy at the University of Florida in Gainesville.

And patients' worries about the safety and effectiveness of once-popular COX-2 medications may have an effect on the reputation of this entire class of drugs.

"I think that the emotional impact with patients will be much more profound than the clinical impact, which will be significant," said Dr. Michael Fleming, chairman of the board of the American Academy of Family Physicians.

"These drugs have provided much-needed relief for a lot of patients with debilitating symptoms, some of whom have been unable to tolerate traditional NSAIDs," said Fleming. "Now they will be afraid as well as confused about what to do about their symptoms. Additionally, the ads from law firms will be in the papers by tomorrow fanning the flames of their fears."

Part of the fear, according to some doctors, is the sheer volume of news stories these announcements generate. "These get embellished to the point where everyone's afraid," said Lema, adding, "I personally took Vioxx for over four years."

All doctors agree, however, that the public should understand that any drug has risks and side effects that may be potentially harmful.

"Every drug is unsafe. Every drug has side effects," said Woosley, who is concerned that additional safety studies may be detrimental. "If we add more delays to getting these drugs out there, we're going to kill the [drug] industry."